BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1081458 · Received July 25, 2008

    Report

    Report Number
    2953200-2008-00599
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: INCORRECT TECHNIQUE/PROCEDURE (MIS-MEASUREMENT ON THE CT SCAN), INHERENT RISK OF PROCEDURE (ARTERIAL AND VENOUS OCCLUSION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE BIFURCATED STENT GRAFT, THE IPSILATERAL LIMB WAS FOUND TO HAVE COVERED THE RIGHT HYPOGASTRIC ARTERY. THIS WAS ATTRIBUTED TO MIS-MEASUREMENT ON THE CT SCAN. THE LEFT HYPOGASTRIC ARTERY WAS PATENT AND THERE WAS COLLATERAL FLOW TO THE RIGHT SIDE; THEREFORE, THE PHYSICIAN ELECTED TO NOT PERFORM ANY ADDITIONAL INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00086916

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other